Related by context. Frequent words. (Click for all words.) 71 Biologics License Application 69 Marketing Authorization Application 69 Complete Response 68 Biologics License Application BLA 67 FDA Accepts 67 supplemental Biologics License Application 65 application sNDA 65 Application BLA 65 Marketing Authorization Application MAA 64 NEBIDO 64 Junovan 64 sBLA 64 BLA submission 63 Act PDUFA date 63 R sorafenib tablets 63 sNDA 63 FDA approvable letter 62 Pivotal Phase III 61 Complete Response letter 61 Clinical Trial Application 61 New Drug Application 61 Investigational Device Exemption 61 BioDelivery Sciences 60 Orphan Drug Status 60 Presents Positive 60 Market Approval PMA 60 Priority Review 60 Orphan Drug status 60 ISTODAX 60 Phase III Clinical Trial 60 FavId 60 Marketing Authorization 59 Entereg R 59 SAR# [004] 59 Marqibo 59 PMA submission 59 Virulizin R 59 ZALBIN 59 TOCOSOL Paclitaxel 59 Exelbine 59 Ixempra 59 Generic Version 59 submitted Biologics License 59 Panzem R 59 Fibrillex TM 59 FIRAZYR 59 Drug Application 59 ONTAK 59 Octreotide 59 Fast Track Designation 59 MOZOBIL 59 Orphan Drug designation 59 submitted Marketing Authorization 59 TRISENOX 58 TYGACIL 58 REPLAGAL 58 Drug Candidate 58 VALSTAR 58 Mutual Recognition Procedure 58 alvimopan 58 IND submission 58 Onsolis 58 Pennsaid R 58 thymalfasin 58 Jevtana 58 taliglucerase alfa 58 Icatibant 58 MNTX 58 Neurodex 58 MONOVISC 58 Patient Enrollment 58 orphan designation 57 Actimmune R 57 ROTATEQ 57 AeroLEF TM 57 ZEGERID Powder 57 Belinostat 57 Solzira 57 Plenaxis R 57 License Application 57 Nexavar ® 57 Azedra 57 EndoTAG TM -1 57 Vilazodone 57 PhosLo 57 subcutaneous formulation 57 ATryn R 57 elotuzumab 57 NVA# 57 methylnaltrexone 57 Omigard 57 liposomal formulation 57 metastatic hormone refractory 57 SCHWARZ PHARMA 57 TRANSDUR Sufentanil 57 BENLYSTA 57 Orphan Drug Designation 57 ALN TTR# 57 L MTP PE 57 deforolimus 56 Pirfenidone